Tracheostomy tube with inner cannula

ABSTRACT

A tracheal tube assembly includes an outer cannula configured to be positioned in a patient airway and an inner cannula configured to be disposed inside the outer cannula. The tracheal tube assembly further includes a flange member secured about the outer cannula, and an outer cannula connector coupled to a proximal end of the outer cannula. The inner cannula includes a proximal end region with features that facilitate insertion and/or removal.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of Provisional Application Ser. No.61/904,319 entitled “Tracheostomy Tube with Inner Cannula, ” filed Nov.14, 2013,which is herein incorporated by reference in its entirety.

BACKGROUND

The present disclosure relates generally to the field of tracheal tubesand, more particularly, to a tracheal tube including an inner cannulawith a compressible end and techniques that may be used in conjunctionwith such tracheal tubes.

This section is intended to introduce the reader to various aspects ofart that may be related to various aspects of the present disclosure,which are described and/or claimed below. This discussion is believed tobe helpful in providing the reader with background information tofacilitate a better understanding of the various aspects of the presentdisclosure. Accordingly, it should be understood that these statementsare to be read in this light, and not as admissions of prior art.

A wide variety of situations exist in which artificial ventilation of apatient may be desired. For short-term ventilation or during certainsurgical procedures, endotracheal tubes may be inserted through themouth to provide oxygen and other gasses to a patient. For otherapplications, particularly when longer-term intubation is anticipated,tracheostomy tubes may be preferred. Tracheostomy tubes are typicallyinserted through an incision made in the neck of the patient and throughthe trachea. A resulting stoma is formed between the tracheal ringsbelow the vocal chords. The tracheostomy tube is then inserted throughthe opening. In general, two procedures are common for insertion oftracheostomy tubes, including a surgical procedure and a percutaneoustechnique.

Such tubes may include an inner cannula, such as a reusable innercannula, or a disposable inner cannula. The inner cannula may bedisposed inside the tracheostomy tube and used as a conduit for liquidsor gas incoming and outgoing into the patient's lungs. The inner cannulamay be removed for cleaning and for disposal of secretions withoutdisturbing the placement of the tracheostomy tube. A connector istypically provided at an upper or proximal end where the tube exits thepatient airway, suitable for coupling the ventilator with the innercannula. In one embodiment, the inner cannula may be removed, cleaned,and reused. In another embodiment, the inner cannula may be disposable,and a new inner cannula may then be positioned inside of the trachealtube. By enabling the cleaning and/or replacement of the inner cannula,a ventilation circuit may be kept clean and free of secretions.

Standard connectors have been developed to allow the tracheal tube tothen be fluidly coupled to artificial ventilation equipment to supplythe desired air or gas mixture to the patient, and to evacuate gasesfrom the lungs. One difficulty that arises in the use of tracheal tubes,and tracheostomy tubes in particular, is in the connection of the tubeto the ventilation equipment. For example, an inner cannula may not beinstalled, or may be installed improperly. This may lead to difficultieswith ventilation when a connection is made to ventilation equipment.

There is a need, therefore, for improved tracheal tubes, andparticularly for improved tracheostomy tubes. It would be desirable toprovide a tube that allows for ease of placement and connection of theinner cannula during ventilation.

BRIEF DESCRIPTION

This disclosure provides a novel tracheal tube designed to respond tosuch needs with a low insertion force and a high retention force. Thetracheal tube may be a tube with a separate inner cannula and outercannula. The inner cannula includes features that allow for ease ofinsertion into the outer cannula. In certain embodiments, the innercannula may include features that facilitate gripping of the proximalregion and compression prior to insertion. In addition, such featuresmay also facilitate gripping and compression prior to removal. Further,in certain embodiments, the insertion or removal may be done by hand orthe tracheal tubes may also be used in conjunction with insertion and/orremoval devices that engage with features of the inner cannula.

In contrast to other types of inner cannula connectors, such as threadedor snap-on connectors, the disclosed embodiments may provide innercannulas that may be inserted and connected in a single movement andthat also resist axial or rotational displacement relative to the outercannula. In particular embodiments, the entire proximal end of the innercannula, including any cap or lip portion, is smaller in diameter thanthe widest portion outer cannula connector when properly inserted. Inthis manner, the outer cannula connector forms the connector portion(e.g., a standard 15 mm connector) for attachment to upstream medicaltubing and/or devices. This is in contrast to disposable inner cannulasthat, when inserted into an outer cannula and connector, have integral15 mm connectors. Accordingly, in the disclosed embodiments, thestandard connector resides on the outer cannula portion of the trachealtube, which may allow the outer cannula assembly to be connected toupstream medical tubing with or without an inserted inner cannula.

Further, the compressible end of the inner cannula may be adhered to orotherwise affixed to the inner cannula to form its proximal end regionor may be manufactured as a unitary assembly, such as a single moldedpiece, which may be a cost-effective manufacturing technique. Thedisclosed tracheal tubes provide improved inner/outer cannula connectionwhile also maintaining standard connections to other medical tubing,such as ventilator tubing.

Thus, in accordance with a first aspect, a tracheal tube assemblyincludes an outer cannula configured to be positioned in a patientairway. The assembly further includes a flange member secured about theouter cannula and an outer cannula connector coupled to a proximal endof the outer cannula. The assembly further includes an inner cannulaconfigured to be disposed inside the outer cannula such that the innercannula and the outer cannula are coaxial. The inner cannula features acompressible proximal region that is configured to be positioned atleast in part in the outer cannula connector. The compressible proximalregion includes a lip configured to be outside of the outer cannulaconnector when the inner cannula is fully inserted in the outer cannula,wherein the lip is a broken annulus separated by one or more opening orslits in a wall of the proximal end region.

In accordance with another aspect, a tracheal tube system includes anouter cannula configured to be positioned in a patient airway; an innercannula configured to be disposed inside the outer cannula such that theinner cannula and the outer cannula are coaxial, wherein the innercannula comprises a compressible proximal region that is configured tobe positioned inside the outer cannula connector and wherein thecompressible proximal region has a compressed configuration comprising afirst diameter when positioned in the outer cannula connector and anuncompressed configuration comprising a second diameter when thecompressible proximal region is unbiased and outside of the outercannula connector; and an insertion or removal device configured topress against an exterior of the proximal region to bias the proximalregion into the compressed configuration, wherein the insertion devicecomprises an opening configured to accommodate the proximal region inthe uncompressed configuration.

Also disclosed herein is a tracheal tube assembly that includes an outercannula configured to be positioned in a patient airway; a flange membersecured about the outer cannula; an outer cannula connector coupled to aproximal end of the outer cannula; and an inner cannula configured to bedisposed inside the outer cannula comprising: a conduit configured to beinserted into an outer cannula to transfer gas to a patient, the conduitcomprising a conduit configured to be inserted into an outer cannula totransfer gas to a patient, the conduit comprising a proximal region,wherein the proximal region is configured to be inserted in an outercannula connector and wherein the proximal region comprises a protrusionconfigured to engage with a complementary window or recess in the outercannula connector.

BRIEF DESCRIPTION OF THE DRAWINGS

Various aspects of the disclosed techniques may become apparent uponreading the following detailed description and upon reference to thedrawings in which:

FIG. 1 is a perspective view of a tracheal tube with a compressibleinner cannula connector inserted into a patient in accordance withembodiments of the present disclosure;

FIG. 2 is a perspective view of the tracheal tube of FIG. 1;

FIG. 3 is a perspective view of a separate inner cannula and outercannula assembly of the tracheal tube of FIG. 1;

FIG. 4 is a section view of the tracheal tube as in FIG. 1 with theinner cannula inserted in the outer cannula;

FIG. 5 is a section view of an embodiment of an inner cannula insertedinto an outer cannula with anti-rotation engagement features inaccordance with embodiments of the present disclosure;

FIG. 6 is a section view of an embodiment of an inner cannula insertedinto an outer cannula with anti-rotation engagement features and aspring-loaded length adjustment feature in accordance with embodimentsof the present disclosure;

FIG. 7 is a section view of an alternative embodiment of an innercannula inserted into an outer cannula with a single anti-rotationengagement feature and a spring-loaded length adjustment feature inaccordance with embodiments of the present disclosure;

FIG. 8 is a top view of a connector region of the inner cannula of FIG.3;

FIG. 9 is a side view of a connector region of an inner cannulaincluding an opening on a compressible ear or wing;

FIG. 10 is a side view of a connector region of an inner cannulaincluding an expanded lip region;

FIG. 11 is a top view of a connector region of an inner cannulaincluding only one engagement feature:

FIG. 12 is a side view of a connector region of an inner cannulaincluding a reduced size engagement feature:

FIG. 13 is a top view of a connector region of an inner cannulaincluding a distally-weighted engagement feature;

FIG. 14 is a partial side view of a connector region of an inner cannulaincluding a separated lip region:

FIG. 15 is a partial side view of a connector region of an inner cannulaincluding a separated lip region with a double-rib support;

FIG. 16A is a partial side view of a connector region of an innercannula including a corrugated region;

FIG. 16B is a partial side view of the connector region of FIG. 16Ashowing the corrugated region when expanded;

FIG. 17 is a partial side view of a connector region of an inner cannulaincluding a separated lip region with slotted supports;

FIG. 18 is a partial section view of the connector region of FIG. 17with the slotted supports positioned in an outer cannula connector;

FIG. 19 is a partial section view of an alternative connector regionwith the slotted supports positioned outside an outer cannula connector;

FIG. 20 is a perspective view of an insertion or removal device:

FIG. 21 is a view of the insertion or removal device of FIG. 20 engagedwith an inner cannula;

FIG. 22 is a view of an alternative annular insertion or removal device;and

FIG. 23 is a view of the insertion or removal device of FIG. 22 engagedwith an inner cannula.

DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS

One or more specific embodiments of the present techniques will bedescribed below. In an effort to provide a concise description of theseembodiments, not all features of an actual implementation are describedin the specification. It should be appreciated that in the developmentof any such actual implementation, as in any engineering or designproject, numerous implementation-specific decisions must be made toachieve the developers' specific goals, such as compliance withsystem-related and business-related constraints, which may vary from oneimplementation to another. Moreover, it should be appreciated that sucha development effort night be complex and time consuming, but wouldnevertheless be a routine undertaking of design, fabrication, andmanufacture for those of ordinary skill having the benefit of thisdisclosure.

The tracheal tubes as provided herein are disposable rather thanreusable, capable of providing differential mechanical ventilation toeither or both lungs, and capable of supporting all other functions ofstandard tracheal tubes (e.g. sealing, positive pressure generation,suctioning, irrigation, drug instillation, etc). The tracheal tubes canbe used in conjunction with all acceptable auxiliary airway devices suchas (e.g. heat and humidity conservers, mechanical ventilatorshumidifiers, closed suction systems, scavengers, capnometers, oxygenanalyzers, mass spectrometers, PEEP/CPAP devices, etc). Furthermore,although the embodiments of the present disclosure illustrated anddescribed herein are discussed in the context of tracheal tubes such astracheostomy tubes, it should be noted that presently contemplatedembodiments may include a tracheal tube assembly including an innercannula with a compressible end used in conjunction with other types ofairway devices. For example, the disclosed embodiments may be used inconjunction with a single-lumen tube, an endotracheal tube, adouble-lumen tube (e.g., a Broncho-Cath™ tube), a specialty tube, or anyother airway device with a main ventilation lumen. Indeed, any devicewith a ventilation lumen designed for use in an airway of a patient mayinclude an inner cannula with a compressible end as provided. As usedherein, the term “tracheal tube” may include an endotracheal tube, atracheostomy tube, a double-lumen tube, a bronchoblocking tube, aspecialty tube, or any other airway device.

Turning now to the drawings, FIG. 1 is a perspective view of anexemplary tracheal tube 10 placed in a patient's airway in accordancewith aspects of the present disclosure. The tracheal tube assembly 10represented in the figures is a tracheostomy tube, although aspects ofthis disclosure could be applied to other tracheal tube structures, suchas endotracheal tubes. The application to a tracheostomy tube is apt,however, insomuch as such tubes tend to be worn for longer periods oftime and, thus, may include a removable and/or disposable inner cannuladisposed inside of an outer cannula 12, which is useful in maintaining aclean ventilation circuit.

The tracheal tube 10 includes an outer cannula 12 that defines aventilation lumen and that facilitates the transfer of gases to and fromthe lungs. The tracheal tube 10 includes an inflatable cuff 16 disposedon the outer cannula 12. However, certain embodiments of the disclosuremay be used in conjunction with cuffless tubes. A proximal end of thetracheal tube 12 may connect to upstream airway devices (e.g., aventilator) via the appropriate medical tubing and/or connectors. Inembodiments that include a cuff 16, a pilot balloon and inflation lineassembly 18 is coupled to the cuff 16.

The outer cannula 12 is illustrated extending both distally as well asproximally from a flange member 20. A pair of side wings of the flange20 extend laterally and serve to allow a strap or retaining member (notshown) to hold the tube assembly 10 in place on the patient. In oneembodiment, apertures formed in each side of the flange member 20 allowthe passage of such a retaining device. In many applications, the flangemember 20 may be taped or sutured in place as well. During intubation,the tracheal tube assembly 10 is placed through an opening formed in theneck and trachea of a patient and extending into the patient airway. Incertain embodiments, the tracheal tube assembly 10 is curved toaccommodate the curved tracheal passageway. For example, the outercannula 12 may be curved in an unbiased state (i.e., outside thepatient) such that an inner curve 22 is generally positioned on aventral side of the patient while the outer curve 24 is positioned onthe dorsal side of the patient when the tracheal tube assembly 10 isinserted in the patient. Further, while a distal portion of the outercannula 12 is inserted within the patient, a proximal portion of theouter cannula 12 forms an outer cannula connector 28. As providedherein, the outer cannula connector 28 receives a proximal end region ofthe inner cannula and forms a secure connection.

FIG. 2 is a perspective view of the tracheal tube assembly 10 showing aninner cannula 30 inserted in the outer cannula 12 and forming aconnection with the outer cannula connector 28. The proximal end region32 is disposed within the outer cannula connector 28 such that aproximal end 34 is exposed (i.e., is not within the outer cannulaconnector 28). The inner cannula 30 is generally coaxial with the outercannula 12 and is shaped to fit within the outer cannula 12 to form thegas conveying passageway to the patient. In this manner, the innercannula 30 may be removed and replaced while the outer cannula 12 isretained. This reduces stress on the stoma wile permitting cleaning ofthe passageway. The outer cannula connector 28 may feature a stepped orthicker coupling portion 29 to couple the connector 28 to the flangemember 20, which extends away from the outer cannula connector 28 intoopposing wing members 31, each including tie holes 33. In oneembodiment, an imaginary axis or line connecting the tie holes 33 may bethe direction of compression for the proximal end region 32, asdiscussed herein.

In certain embodiments of the present techniques, the inner cannula 30may be manually inserted into the outer cannula 12. As shown in FIG. 3,the inner cannula 30 may be inserted by pushing the distal end 40through the proximal end 44 of the outer cannula 12, e.g., in thedirection of arrow 46. The insertion is complete when the distal end 40is generally located at or near the distal end 48 of the outer cannula12. In certain embodiments, the distal end 40 of the inner cannula 30terminates short of the distal end 48 of the outer cannula and isdisposed entirely within the outer cannula. When the inner cannula 30 isfully or suitably inserted to facilitate patient ventilation, theproximal end region 32 is disposed at least in part within the outercannula connector 28. In embodiments in which the outer cannula forms acurve, such as a Magill curve, the inner cannula 30 may also be curvedin a complementary fashion. Accordingly, the insertion may bedirectional such that proper insertion involves an inner curve 50 of theinner cannula 30 located proximate to or corresponding with the innercurve 22 of the outer cannula 12. Similarly, the outer curve 52 of theinner cannula 30 will be located proximate to the outer curve 24 of theouter cannula 12. The positioning of the inner cannula 30 in the outercannula 12 may be facilitated by operator technique and, in particularembodiments, with the aid of markings, instructions, or other visualindicators.

The inner cannula 30 forms a conduit from which liquids or gases,including medications, may enter through the proximal end 34. Asdepicted, the proximal end region 32 forms part of the connector regionof the inner cannula 30, while an inserted portion 53 forms most of themain body of the inner cannula 30. The inserted portion 53 that extendsinto the patient airway to the distal end 40 is coupled to a narrowingor tapered region 54 of the proximal end region 32 and is generallysized and shaped to facilitate insertion within the main body of theouter cannula 12. Both the inner cannula 30 and the outer cannula 12have dimensions selected to fit easily through the stoma. In practice, arange of such tubes may be provided to accommodate the differentcontours and sizes of patients and patient airways. Such tube familiesmay include tubes designed for neonatal and pediatric patients as wellas for adults. By way of example only, the outer cannula 12 of the tube10 may range from 4 mm to 16 mm. The inner cannula 30 may be sized tocorrespond with an appropriate outer cannula 12. The outer cannula 12and the inner cannula 30 may be characterized by their inner diameters(referring to the diameter of the interior of the passageway) or theirouter diameters (referring to the diameter as measured from the exterioroutside wall to exterior outside wall).

Because the inner cannula 30 fits within the outer cannula 12, the outercannula 12 features a larger inner diameter 60 relative to an outerdiameter 64 of the inserted portion 53 of the inner cannula 30. Theouter diameter 64 of the inserted portion 53 of the inner cannula 30 maybe selected to allow sufficient air flow while also fitting comfortablywithin the outer cannula 12 and allowing for appropriate insertionforce. The inner diameter of the outer cannula 30 is less than the outerdiameter 64 by the thickness of the walls of the inner cannula 30. Forexample, an inner cannula 30 sized to 6.5 mm may have an outer diameter64 of about 6.5 mm and an inner diameter of about 5.5 mm. In such anembodiment, the inner cannula walls are about 1 mm thick in the insertedportion of the inner cannula 30 (e.g., in portions distal of theproximal end region 32). Similarly, a 10 mm inner cannula 30 may have aninner diameter of about 9 mm. Accordingly, tubes sized to 6.5 mm, 7.0mm, 7.5 mm 8.0 mm, 8.5 mm, 9.0, or 10 mm may feature smaller innerdiameters that define the airflow passage.

Further, the inner diameter 62 at the proximal end 44 of the outercannula 12 is typically larger than the inner diameter 60 and isselected to couple to appropriate tubing. That is, the outer cannula 12is narrower in the inserted portion and is wider at the connector. Theproximal end region 32 also has a larger outer diameter 70 relative tothe inserted portion 53. In certain embodiments, the proximal end regionmay flare or taper outwards gradually such that the diameter increasesgradually, with the largest diameter 70 at the proximal end 34. In otherembodiment, the proximal end region 32 may include a generallybarrel-shaped region with an outer diameter 70. It should be understoodthat the proximal end region 32 may change under compression.Accordingly, the outer diameter 70 refers to the uncompressedconfiguration. Further, in embodiments in which the proximal end 34forms a broken annulus (i.e., is not a continuous element), the outerdiameter 70 refers to a diameter between the solid portions of theproximal end 34. When the proximal end region 32 is within the outercannula connector 28, the outer cannula connector 28 provides a biasingforce that compresses the proximal end region 32 into a compressedconfiguration that is sized to fit within the inner diameter 62 of theouter cannula connector 28. The outer diameter 70 is larger than alargest outer diameter of the inner cannula 30 in the compressedconfiguration.

FIG. 4 is a section view of an inner cannula 30 positioned within theouter cannula 12. When the inner cannula 30 is in the compressedconfiguration, the proximal end region 32 is constrained by the wall 82of the outer cannula connector 28. Accordingly, the outer diameter 84 issmaller than the outer diameter 70 (see FIG. 3) of the uncompressedconfiguration. In one embodiment, the outer diameter 84 is about 15 mmor slightly smaller. That is, uncompressed outer diameter 70 is aboutthe outer diameter of a 15 mm connector. The resulting proximal opening86 of the inner cannula 30 is also smaller. In a specific embodiment,the material of the proximal end region 32 is selected so that anoperator is capable of changing the configuration of the proximal endregion 32 through the application of a biasing force. Similarly, thewall 82 of the outer cannula connector 28 is sufficiently strong tomaintain the proximal end region 32 in the compressed configuration.

The outer cannula connector 28 may be formed in accordance with industrystandards to permit and facilitate connection to ventilating equipment(not shown). By way of example, the outer cannula connector 28 is a 15mm connector, although other sizes and connector styles may be used.Additionally, the tracheal tube assembly 10 may be connected to othermedical devices, such as a suction device, a T-junction, a medicinedelivery system, and so forth. Indeed, the outer cannula connector 28may enable the attachment of one or more medical devices to the trachealtube assembly 10. To accommodate such a connection, the proximal endregion 32 may be formed such that, when inserted, the inner cannula 30does not interfere with coupling via the outer cannula connector 28. Tothat end, in particular embodiments, the widest diameter 84 of the innercannula 30, including any protruding portions, is smaller than thewidest outer diameter (e.g., 15 mm) of the outer cannula connector 28.It should be understood that, the inserted portions of the proximal endregion 32 press against the wall 82 of the outer cannula connector 28and feature an outer diameter that is slightly smaller (e.g., 12 mm orsmaller) than the inner diameter of the outer cannula connector 28.Further, the inner cannula 30 may feature regions with different outerdiameters along its length in either configuration.

Because the inner cannula 30 is configured to be inserted and/or removedby an operator, the proximal end 34 may protrude from the outer cannulaconnector 28 to allow the proximal end region 32 to be manipulated whilethe inner cannula 30 is in place. For example, the proximal end 34protrudes proximally or along a rotational axis 87 of the outer cannulaconnector 28. The axis 87 is generally orthogonal to the axis 88 along alongest dimension of the flange member 20. When inserted in the patient,the inner cannula. 30 may be positioned so that the operator grips theproximal end and pushes laterally (e.g., along the axis 88).

In addition to a compressible connector portion (e.g., the proximal endregion 32) of the inner cannula 30, the inner cannula 30 may alsoinclude features that engage with the outer cannula 12 and/or the outercannula connector 28 to promote alignment and prevent rotation ordislodgement of the inner cannula 30 relative to the outer cannula 12.As shown in FIG. 5, which is a sectional view of an inner cannula 30coupled to an outer cannula 12, the inserted portion 53 includes latches90 that engage with complementary windows 92 through the wall 82 of theouter cannula connector 28. In the depicted embodiment, the latches 90may be sized at shaped to extend beyond the windows 92 such that thelatches 90 protrude from the wall 82. In other embodiments, the latches90 may be flush with or recessed within the wall 82, depending on thesize and shape of the latch 90. Further, in embodiments in winch thewindows 92 extend completely through the wall 82, the engagement of thelatches 90 is visible from the exterior of the outer cannula connector28, providing a visual check for proper alignment.

In embodiments in which the latches 90 are not disposed on thecompressible proximal end region 32, the latches 90 may be formed from acompliant material that compresses or bends to allow progress if theinner cannula 30 within the outer cannula connector 28. Uponencountering the windows 92, the latches may then assume an uncompressedconfiguration. In one embodiment, the latches 92 may be hollow barbs.Further, the latches may also be shaped to point or curve generallytowards the proximal end 34 to encourage smoother progress of the innercannula 30 within the outer cannula connector 28.

In certain embodiments, the latches 90 may be positioned on the innercannula 30 to be within the inner cannula connector 28 and not the moredistal portion inserted portion 96 of the outer cannula 12. In oneembodiment, the latches 90 may be positioned opposite one another aboutthe circumference of the inner cannula 30. In the depicted embodiment,the latches 90 are aligned with the wings of the flange member 20. Suchpositioning may be advantageous in embodiments in which the compressionand decompression of the proximal end region 32 is also along an axisconnecting the wings of the flange member 20. Although the latches 90may not be directly compressed upon compression of the proximal endregion 32, the material of the inserted portion 53 may nonetheless bendor compress slightly in areas of the inner cannula. 30 adjacent to andaligned with the compression points to allow smoother insertion of theprotruding latches 90.

FIG. 6 is an alternate embodiment in which the inner cannula 30 includesa spring 100 to facilitate alignment of the latches 90 within thewindows 92. The spring 100 may be integral with the body of the innercannula 30 in just a portion of its length. Compression of the springtowards the distal end helps move the latches 90 distally. The spring100 may be positioned adjacent to the latches 90, either on a proximalor distal side. FIG. 7 shows another embodiment with a single latch 90that engages with a window 92 that does not extend completely throughthe wall 82 of the outer cannula connector 28. Such an embodiment maypermit a smaller-sized latch 92, which may allow a lower cannulainsertion force. Further, such an embodiment may be used when the latch90 is positioned to align with the coupling portion 29 (see FIG. 2) ofthe outer cannula connector 28. While the depicted embodiment isimplemented in conjunction with the spring 100, it should be understoodthat the spring 100 may also not be used.

FIG. 8 is a perspective view of an inner cannula 30 in the uncompressedconfiguration. In the depicted configuration, the proximal end 34assumes its largest unbiased outer diameter 70. Further, in the depictedembodiment, the inner cannula 30 includes a plurality of opening 110that facilitate compression. When force is applied to compress the firstear 112 and the second ear 114, these structures move towards oneanother (e.g., along axis 88, see FIG. 4) and the gap 116 formed by theopenings 90 decrease as the proximal end region 32 assumes the smaller,compressed outer diameter 84 (see FIG. 4). For example, an applicationof 5N of force or less may be applied to achieve sufficient compressionto insert the inner cannula 30. In other embodiments, the proximal endregion 32 may form a single gripping structure (e.g., may have noopening 110) or more than two ears.

The opening 110 allows the proximal end 34 of the inner cannula 30 toform a smaller compressed diameter 84 under a compression force withoutwrinkling and while maintaining a generally circular cross-section overthe inserted portion of the proximal end region 32 that corresponds withthe generally circular cross-section of the outer cannula connector 28.The size and number of openings 110 may be selected according to thesize and manufacturing of the inner cannula 30. In one embodiment, theproximal end region has two openings 110. In embodiments with only oneopening 110, the size of the gap 116 in the uncompressed configurationmay be relatively larger to facilitate the change from uncompressed tocompressed with fewer openings. Further, the openings 110 may bedifferently-sized relative to one another. The size of the gaps 116 maybe measured in either the compressed or the uncompressed configuration,and may be a largest space between the adjacent portions of the innercannula wall 120.

In the depicted embodiment of an inner cannula 30 including one or moreopenings 110, the opening 110 may terminate at a furthest distalterminus 124. The more distal the distal terminus 124 is, the greaterthe degree of compression of the proximal end region 32. Accordingly, incertain embodiments, it may be desirable to include at least oneelongated opening 110 to achieve more compression. For example thedistal terminus 124 may be positioned at least to be at of more distalthan the junction 126 between a more barrel-shaped region 128 and thetapered region 54. In other embodiments, the distal terminus 124 may bepositioned within the tapered region 54 between the junction 126 and ajunction 130 between a narrowest point of the tapered region 54 and theinserted portion 53. In this manner, greater compression of anyprotruding features may be achieved, including, e.g., support ribs 132and mating features, such as protrusions 134. Further, the distalterminus 124 may be rounded, as depicted, or may be the tip of aV-shaped opening 110 for even greater potential compression.

The openings 110 may be positioned to correspond with a dorsal andventral side of the tube 10 (e.g. to correspond with the inner curve 50and the outer curve 52 of the inner cannula, see FIG. 3) when insertedto encourage lateral compression. In other embodiments, the openings 110may be positioned to laterally to facilitate compression along adorsal-ventral axis.

FIG. 9 is a side view of an alternate configuration of proximal endregion 32 that includes one or openings 146. The openings 146 mayprovide an improved gripping surface on one or more ears, e.g., ear 112.As depicted, the opening 146 is aligned with the protrusion 134. Wherethe protrusion 134 may impede gripping device or finger, the opening mayprovide increased space for a finger to find purchase on the exteriorsurface 148 of the proximal end region 32. Further, in embodiments inwhich the more proximal portion 150 of the barrel-shaped region 128 hasa slightly wider diameter relative to the adjacent portion 152, theopenings 146 provide more space into which the wall 120 of the innercannula 30 can compress (e.g., in multiple directions) under force.

The proximal end 34 may also terminate in a lip 160 that is formed inthe wall 120, shown in FIG. 10. The relatively thicker lip 160 may alsoextend at least partially towards the distal terminus 124 and mayfurther include an abutment surface 162. The abutment surface 162 isconfigured to abut the proximal end 44 of the outer cannula connector 28and prevent further movement of the inner cannula 30 distally, which mayassist in aligning the inner cannula 30 within the outer cannula 12. Incertain embodiments, a distance 164 from the abutment surface 162 to theproximal end 34 is less than a distance from the proximal end 34 to thedistal terminus 124 (see FIG. 8). In particular embodiments, thedistance 164 is less than 50% of the distance from the proximal end 34to the distal terminus 124. In a particular embodiment, the distance 164is about 4 mm. Further, in another embodiment, the proximal lip 160 maybe about 2.7 mm or more in thickness. During, insertion, although anoperator may grip the proximal end region 32 more generally, as more ofthe inner cannula 30 is positioned within the outer cannula 12,eventually the available gripping surface decreases. The proximal lip160 provides gripping surface for the operator during the entireinsertion.

As noted, in particular embodiments, the proximal end region 32 mayinclude mating features that couple to complementary features on theinterior wall of the outer cannula connector 28 (see FIG. 4). Suchmating features may prevent rotational movement of the inner cannula 30relative to the outer cannula connector 28. In addition, the matingfeatures may provide additional alignment to facilitate correctalignment of the curve of the inner cannula 30 with the curve of theouter cannula 12 (see FIG. 3). As depicted in FIG. 11, the matingfeatures may be protrusions, such as protrusion 134 formed on anexterior surface 120 of the inner cannula. 30 in the proximal end region32. The protrusion 134 may be formed in any suitable shape orcombination of shapes, such a rounded bump, a ramp shape, a pyramidstructure, etc. Further, the proximal end region 32 may include anynumber of protrusions 134 positioned about a circumference. For example,the proximal end region 32 may include two protrusions 134 that opposeone another. In specific embodiments, opposing protrusions 134 may becircumferentially centered on the ears 112 and 114. In such embodiments,the protrusions 134 may serve as guides for an operator to press againstto bias the ears 112 and 114 towards one another. In another embodiment,the protrusions 134 may be about 90 degrees from opposing notches 90. Inanother embodiment, respective protrusions 134 may be provided as apartial ring with an arc having less than 45° of circumference of theproximal end region 32. In another embodiment, the protrusion 134 mayform a ring about the circumference of the proximal end region 32.

It should be understood that the mating features may also be implementedas recesses or a combination of protrusions and recesses. The size ofthe protrusion 134 may be selected to fit into it corresponding recessin the outer cannula connector 28 and may be less than a thickness ofthe wall of the outer cannula connector 28. In one embodiment, theprotrusion 134 may protrude less than about 1 mm, less than about 1.5 mmor less than about 2 min from the exterior surface 120. In particularembodiments, the protrusions 134 protrude less than a widest diameter 70in an uncompressed configuration. Alternatively, the protrusion 134 mayfit into complementary windows formed in the outer cannula connector. Insuch embodiments, the protrusion 134 may be larger. The inner cannula 30may also include additional support structures, such as one or more ribs132. In the depicted embodiment, the rib 132 may provide structuralsupport to the protrusion 134. In addition, the tapered region 54 may beformed proximate to the protrusion 134 to facilitate insertion of therelatively larger protrusion 134 into the inner cannula connector 28.

FIG. 11 is a top view of the inner cannula connector having a singleprotrusion 134. Such an embodiment may be associated with a lowerinsertion force for the inner cannula 30, as the protrusions 134 mayincrease friction along the interior of the inner cannula connector 28.Further, a single protrusion 134 may be more readily aligned with asingle complementary recess formed on the interior of the inner cannulaconnector 28. In certain embodiments, the protrusion/s 134 may bepositioned to align with the distal terminus 124 of an opening 110. Inother embodiments, the protrusions may be positioned to be proximal ofthe distal terminus 124.

FIG. 12 is an alternate embodiment showing a protrusion 134 with areduced surface area and volume relative to the protrusion 134 of FIG.11. The size of the protrusion 134 may be related to the insertion forceinvolved in correctly positioning the inner cannula 30 within the outercannula connector 28. Larger protrusions 134 may have larger insertionforces. The depicted embodiment may be used to achieve a lower insertionforce, for example for inner cannulas 30 sized for pediatric use. Inparticular embodiments, protrusions 134 may be differently-sized and/orshaped depending on their inner diameter. The complementary recess onthe outer cannula connector 28 may also be sized to only accept an innercannula 30 having a protrusion 134 of a certain size and/or shape, thusreducing the possibility of having an incorrectly-sized inner cannula 30inserted. In one embodiment, the protrusions 134 may increase as theinner diameter of the inner cannula 30 increases, allowing a quickvisual confirmation for the operator that a larger or smaller innercannula 30 has been selected from a collection of cannulas of multiplesizes. FIG. 13 is another alternate embodiment showing a protrusion 134a with only a more proximal half of its volume removed relative to itsopposing protrusion 134 b. Removal of protruding volume in the widerdiameter portion of the proximal end region 32 may facilitate insertionof the inner cannula. 30 with lower insertion forces. While the depictedembodiment shows the protrusions 134 a and 134 b and beingasymmetrically-sized, it should be understood that one or all of theprotrusions 134 may be configured to position a majority of theprotruding volume more distally relative to symmetrically-configuredprotrusions 134.

The proximal end region 32 may also include additional features toenhance insertion of the inner cannula 30. FIGS. 14-19 depict variousembodiment of proximal end regions 32 including cutouts 170 thatseparate the proximal lip 160 from the adjacent section 172. The cutouts170 may be positioned to form short arc or longer arcs about thecircumference of the proximal end region, and may be present in anysuitable number. The cutouts 170 are separated by one or more supportpillars 174. Further, the proximal end region 32 may or may not includeany openings 110. If one or more openings 110 are present, the cutouts170 may be positioned within one or more of the ears 112 and 114. If noopenings 110 are present, in one embodiment, the cutout 170 may be asingle almost complete annulus interrupted by a support pillar 174. Inthis manner, the proximal lip 160 may form a hinged pull ring that maypivot away from the proximal end region to facilitate removal of theinner cannula 30. FIG. 15 is an alternate embodiment in which theproximal end region 32 includes two support pillars 174 spaced apartfrom one another to reinforce the strength of the hinged connection withthe proximal lip 160. Further, the particular features of the innercannula 30 may be combined or exchanged with one another. In thedepicted embodiment, the protrusion 134 is also reduced in size tofacilitate insertion.

In other embodiments, as shown in FIGS. 16A and 16B, the proximal endregion may include a bellows 180 configured to expand when a force isapplied in the direction of arrow 182, shown in FIG. 16A. In thismanner, the proximal lip 160 moves away from the outer cannula connector28 to allow more room for a finger or other device to grasp the proximallip and remove the inner cannula. The cutouts 170 also allow additionalroom to facilitate engagement with the proximal lip 160. FIG. 16B showsthe bellows 180 in the expanded configuration. For example, the bellows180 may expand from about a 4 mm size (including a distance from thebellows 180 to the proximal lip 160) to a 10 mm size. The bellows 180may be formed integrally with the material of the proximal end region32. For example, the bellows 180 may be formed by molding a corrugatedsection into the proximal end region during, manufacturing. In addition,to accommodate the bellows 180, any protrusions 134 present may belocated relatively distally (e.g., adjacent to the junction with supportribs 132) or may be reduced in size.

As shown in FIG. 17, the proximal end region 32 may include any suitablecombination of cutouts 170 and support pillars 174. Further, whilecertain embodiments may yield a proximal lip 160 coupled to the adjacentsection 172 via a single hinge, the proximal lip 160 may still functionas a pull ring even when coupled to the adjacent section 172 at multiplelocations. The cutouts 170 may allow sections of the proximal lip tobend away from the adjacent section to facilitate insertion and/orremoval.

Depending on the configuration of the adjacent section 172, the cutouts170 may be positioned within (FIG. 18) the inner cannula connector 28when the inner cannula is properly inserted or outside (FIG. 19) theinner cannula connector 28. For example, the adjacent section 172 mayinclude a feature (e.g., a groove 190) that engages with a complementaryfeature near the proximal end 44 of the inner cannula connector 28.Depending in the configuration, the adjacent section 172 may be about 4mm from the proximal end 34. In such an embodiment, the proximal lip isspaced apart from the proximal end 44 when the inner cannula 30 isinserted. The cutouts 170 provide a recess for improved engagement withthe proximal lip.

In additional to features such as pull rings, the present techniques mayinclude tools for facilitating inner cannula 30 removal and/orinsertion. FIG. 20 shows an example of an insertion and/or removaldevice 200. The device may include a first member 202 and a secondmember 204 configured to engage opposing sides of a proximal end regionof an inner cannula. The device 200 may also include engagement featuressuch as gripping teeth 210 or a series of grooves and ridges configuredto mate with complementary features on the inner cannula proximal end.To permit biasing of the first member 202 and the second member 204toward one another, the device 200 may include a slit 212 that contractswhen a biasing force is applied. FIG. 21 shows the device 200 engagedwith the inner cannula 30, for example via gripping surface features.220 on the proximal end region 32 engaged with the gripping teeth 210.The device 200 may be used to insert or remove the inner cannula 30 fromthe outer cannula 12 and the outer cannula connector 28. FIG. 22 showsan alternate device 200 in the form of a compressible annulus 230 thatmay be grasped and, optionally, supported via a thumb or finger hold232. FIG. 23 is a top view of the device 200 engaged with the proximalend region 32. The device 20 may be formed from a material resilientenough to compress the proximal end region under a biasing force appliedby an operator, e.g., a plastic or metal. The device 200 may alsoinclude a shape memory material.

It is envisioned that the tracheal tube assembly 10, which may includethe insertion and/or removal device 200 as provided herein, may beprovided as an assembly and/or as a kit. A kit may include a packagingthat encloses an inner cannula 30 sized for an outer cannula 12, whichmay include an affixed outer cannula connector 28 and flange member 20.The kit may also include a neck strap for retaining the tracheal tube 10in place. The kit may also include an obturator. Other components of thekit may include a cap configured to be placed on a proximal end 34 whilethe obturator is in use and that may be part of the obturator. The tubeassembly 10 components (e.g., outer cannula 12, flange member 20, outercannula connector 28, cuff 16, and pilot balloon assembly 18) may beassembled prior to in situ assembly of the inner cannula 12 into theouter cannula 14. Indeed, the user or clinician may perform finalassembly of the tracheal tube 10 by selecting a desired inner cannula 30from a selection of inner cannulas and then inserting the inner cannula30 into the outer cannula 12 prior to intubation, either by hand or withan insertion device 200. Thus assembled, the tracheal tube 10 may thenbe inserted into the patient's trachea.

It should be understood that any of the disclosed embodiments may becombined or exchanged with one another. By way of example only, it isenvisioned that the inner cannula 30 may have one or more of thedisclosed latches, windows, openings, proximal lips, cutouts, supportribs, pull rings, etc.

Components of the tube assembly 10 may be manufactured according tosuitable techniques. For example, the inner cannula and/or outer cannula12, including the outer cannula connector 28, may be molded, overmolded,two shot molded, computer numerical control (CNC) machined, milled, orotherwise formed into the desired shape. In one embodiment, a mold ormold form may be used to manufacture the inner cannula 30. In oneembodiment, the mold or other manufacturing technique may facilitate aspeckled outer surface of the inner cannula 30, which may facilitateinsertion. One or more components may be manufactured of materials suchas a polyethylene (e.g., low density polyethylene), polypropylene, PTFE,expandable PTFE, polyvinyl chloride (PVC), a PEBAX silicone, apolyurethane, thermoplastic elastomers, a polycarbonate plastic, asilicon, or an acrylonitrile butadiene styrene (ABS). In particularembodiments, the material of the inner cannula 30 may be selected to be60 Shore D.

While the disclosure may be susceptible to various modifications andalternative forms, specific embodiments have been shown by way ofexample in the drawings and have been described in detail herein.However, it should be understood that the embodiments provided hereinare not intended to be limited to the particular forms disclosed.Indeed, the disclosed embodiments may not only be applied to airwaydevices, but these techniques may also be utilized for connectionsbetween inner and outer conduits for other types of medical devices andmedical connective tubing. Rather, the various embodiments may cover allmodifications, equivalents, and alternatives falling within the spiritand scope of the disclosure as defined by the following appended claims.

What is claimed is:
 1. A tracheal tube assembly comprising: an outercannula configured to be positioned in a patient airway; a flange membersecured about the outer cannula; an outer cannula connector coupled to aproximal end of the outer cannula; an inner cannula configured to bedisposed inside the outer cannula such that the inner cannula and theouter cannula are coaxial, wherein the inner cannula comprises acompressible proximal region that is configured to be positioned atleast in part in the outer cannula connector and wherein thecompressible proximal region of the inner cannula comprises a lipconfigured to be outside of the outer cannula connector when the innercannula is fully inserted in the outer cannula, wherein the lip is abroken annulus separated by one or more opening or slits in a wall ofthe compressible proximal region of the inner cannula.
 2. The assemblyof claim 1, wherein the openings or slits narrow distally and interruptthe lip such that the lip is a broken annulus.
 3. The assembly of claim2, wherein the openings or slits are positioned on opposing sides of thecompressible proximal region of the inner cannula such that thecompressible proximal region of the inner cannula forms two opposingwings.
 4. The assembly of claim 3, comprising a window in each of thetwo opposing wings.
 5. The assembly of claim 3, wherein the compressibleproximal region comprises only one opening or slit, and wherein theopening or slit terminates adjacent to a tapered portion of the innercannula that narrows towards a distal end.
 6. The assembly of claim 1,wherein the compressible proximal region comprises a plurality ofopenings partially separating the lip from an adjacent portion of theproximal end region.
 7. The assembly of claim 6, wherein the lip isjoined to the adjacent portion by one more ribs.
 8. The assembly ofclaim 6, wherein the lip is configured to be a pull ring to facilitateremoval of the inner cannula from the outer cannula and wherein the lipis configured to bend partially away from the adjacent portion when theinner cannula experiences a removal force.
 9. The assembly of claim 1,wherein the compressible proximal region comprises a plurality ofprotrusions spaced apart from one another and positioned distally fromthe lip.
 10. The assembly of claim 9, wherein the plurality ofprotrusions are different sizes.
 11. The assembly of claim 1, whereinthe compressible proximal region comprises a corrugated regionconfigured to expand in length under an inner cannula removal force tofacilitate movement of the lip away from the outer cannula connector.12. A tracheal tube system comprising: an outer cannula configured to bepositioned in a patient airway; an inner cannula configured to bedisposed inside the outer cannula such that the inner cannula and theouter cannula are coaxial, wherein the inner cannula comprises acompressible proximal region that is configured to be positioned insidethe outer cannula connector and wherein the compressible proximal regionhas a compressed configuration comprising a first diameter whenpositioned in the outer cannula connector and an uncompressedconfiguration comprising a second diameter when the compressibleproximal region is unbiased and outside of the outer cannula connector;and an insertion or removal device configured to press against anexterior of the proximal region to bias the proximal region into thecompressed configuration, wherein the insertion device comprises anopening configured to accommodate the proximal region in theuncompressed configuration.
 13. The tracheal tube system of claim 12,wherein a tip of the proximal region extends out of the outer cannulawhen the inner cannula is fully inserted in the outer cannula andwherein the insertion or removal device is configured to directlycontact the tip to compress the proximal region.
 14. The tracheal tubesystem of claim 12, wherein the opening comprises mating featuresconfigured to engage complementary features on the exterior of theproximal region.
 15. The tracheal tube system of claim 14, wherein themating features comprise grooves or teeth.
 16. The tracheal tube systemof claim 12, wherein the insertion or removal device comprises acompressible annulus configured to compress about the proximal region.17. The tracheal tube system of claim 12, wherein the insertion orremoval device comprises a first member and a second member configuredto move towards one another to compress the proximal region.
 18. Thetracheal tube system of claim 12, wherein the system is assembled in akit.
 19. The tracheal tube system of claim 12, wherein the insertion orremoval device is configured to engage a pull ring on the inner cannula.